FDA approval · Drugs@FDA
INVOKAMET XRcanagliflozin, metformin hydrochloride
NDA205879 ·
FDA approved the original new drug application for INVOKAMET XR on September 20, 2016, sponsored by JANSSEN PHARMS. FDA has approved 5 efficacy supplements on the application since, the most recent on December 18, 2024.
- Application
- NDA205879
- Sponsor
- JANSSEN PHARMS
- Original approval
- Review
- standard review
- Submission class
- Type 4 - New Combination
- Active ingredient
- canagliflozin, metformin hydrochloride
Browse every approval whose brand starts with I, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| canagliflozin 150MG; metformin hydrochloride 500MG | TABLET, EXTENDED RELEASE | ORAL | Prescription |
| canagliflozin 50MG; metformin hydrochloride 500MG | TABLET, EXTENDED RELEASE | ORAL | Prescription |
| canagliflozin 150MG; metformin hydrochloride 1GM | TABLET, EXTENDED RELEASE | ORAL | Prescription |
| canagliflozin 50MG; metformin hydrochloride 1GM | TABLET, EXTENDED RELEASE | ORAL | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
| Approved | Supplement | Review |
|---|---|---|
| S-2 | standard | |
| S-7 | standard | |
| S-11 | standard | |
| S-17 | standard | |
| S-23 | priority |
FDA records other approved supplements on this application, by the class code it assigns them: Labeling 10. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
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